A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
This Phase1/2, open label, multicenter study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with NSCLC having EGFR and/or HER2 mutations. Phase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643, both as a monotherapy and in combination with chemotherapy. Phase 2 will further evaluate the antitumor efficacy and safety in specified cohorts determined by EGFR/HER2 mutation subtypes and/or treatment history at the RP2D, as well as the population PK.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 5, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- BlossomHill Therapeutics
- Interventions being studied
- Drug: BH-30643; Drug: BH-30643 combo therapy with Carboplatin/Pemetrexed; Drug: BH-30643
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- ≥ 18 years or legal adult.
- Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC with EGFR or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21.
- Has at least 1 measurable target extracranial lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group Performance Status ≤ 1.
- Has a life expectancy of ≥ 3 months.
- Has adequate hematologic, hepatic, and renal function.
- The above are a summary; other Inclusion Criteria details may apply.
- History of any concurrent malignancy within the previous 2 years.
- Known other oncogenic driver alterations (eg, moderate or high MET amplification) or histological transformation (eg, to small cell carcinoma, etc.).
- Unresolved toxicities from prior therapies.
- Any significant and uncontrolled medical condition, such as infection.
- Active or history of interstitial lung disease from any cause
- Clinically significant cardiovascular event within 6 months or significant history of major organ.
- The above are a summary; other
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Mayo Clinic Hospital - ArizonaPhoenix, Arizona
- The Regents of the University of California - Irvine, CA CampusIrvine, California
- UC San Diego Moores Cancer CenterLa Jolla, California
- University of California, Davis Comprehensive Cancer CenterSacramento, California
- Stanford University Medical CenterStanford, California
- Yale University - Cancer CenterNew Haven, Connecticut
- Georgetown University Medical CenterWashington D.C., District of Columbia
- Mayo Clinic - FloridaJacksonville, Florida
- Sarah Cancer Research Institution - Florida Cancer SpecialistOrlando, Florida
- Moffitt Cancer CenterTampa, Florida
- Northwestern Medicine - Northwestern Memorial Hospital Galter PavilionChicago, Illinois
- Massachusetts General HospitalBoston, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 5, 2026. Always confirm current availability with the study team.